FDA-Drug2025-12-17Class IICHEMICAL
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Hazard
Incorrect Product Formulation
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide.
Affected count
2980 syringes
Manufactured in
8710 E 34th St N, N/A, Wichita, KS, United States
Products
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2026Want us to check the next one for you?
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